Compressive Elastic Dressing Versus TR Band

Coronary Artery Disease Clinical Trial

— Band Vs Gauze  

Official title:

Comparison Between Compressive Elastic Dressing and Hemostatic TR Band Following Cardiac Intervention Utilizing the Radial Technique: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05409716
• Other study ID #: TR-Band Vs Gauze Swab
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: September 2022
• Source: An-Najah National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Radial approach is widely established in cardiac diagnostic and therapeutic treatments. It has been shown to decrease bleeding, vascular problems, and mortality rates when compared to the femoral approach. It also offers better comfort to patients through early mobility and lowers hospital expenses.

Previously, there were no specific devices for radial artery hemostasis. Many different types of dressings were used in various hospitals with no standardization. This raises the question of whether specific devices surpass dressings in terms of patient comfort, time required to maintain hemostasis, and vascular complications.

The primary goal of this study was to examine the effectiveness of compression dressings and hemostatic wristbands on patients undergoing cardiac procedures via radial approach in terms of patient comfort, time required to maintain hemostasis, and vascular problems.

The hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized in one group, while compressive elastic dressing, standardized as 13 threads gauze overlapped, opened, longitudinally pleated once and wrapped, making a 5-cm long cylinder, 1-cm in height, was used in the other.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Patients who agree to participate in the study and sign the consent form.

• Patients with an indication for coronary catheterization

• Clinically stable patients

• Patients with palpable pulses on at least one of the radial arteries.

Exclusion Criteria:

• Patients who are hemodynamically unstable (systolic blood pressure less 90mmhg)

• Patients with radial AV shunt for hemodialysis

• Patients with previous CABG using radial artery

• Patients with Renaud phenomenon or lymphedema

• Patients who had vascular problems at the puncture site before the hemostasis process started.

• Failure to obtain radial access

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Chest Pain
• Coronary Artery Disease
• Heart Diseases
• Infarction
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia
• Non ST Elevation Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• NSTEMI
• STEMI

Intervention

Procedure:
• Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach
Following cardiac procedure using radial approach, compressive elastic dressing, standardized as 13 threads gauze overlapped, opened, longitudinally pleated once and wrapped, making a 5-cm long cylinder, 1-cm in height, fixed with elastic crepe bandage was used to achieve hemostasis.
• Wristband TR band for hemostasis in cardiac procedure using radial approach
Following cardiac procedure using radial approach, hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized was used to achieve hemostasis.

Locations

Country	Name	City	State
Palestinian Territory, occupied	An-Najah National University Hospital	Nablus	West Bank
Palestinian Territory, occupied	An-Najah National University Hospital	Nablus

Sponsors (1)

Lead Sponsor	Collaborator
An-Najah National University

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compression "hemostasis" time	The time from the placement of the hemostatic Wristband or Compressive dressing until its removal (when there's no blood oozing after removal), measured by minutes.	Up to 240 minutes after placement
Primary	Number of patient with Hematoma and Grade of hematoma	It is defined by EASY hematoma scale.	Within 24 hours after the procedure
Secondary	Number of patient with Radial artery occlusion	Radial artery patency was checked by evaluating radial pulse, capillary refill, hand color, temperature, and assessing the puncture site and hand for any hematoma or bleeding. In the event of an access site hematoma or any other ischemia sign, the patient will be sent to the radiology department for further assessment with radial artery Doppler.	Within 24 hours after the procedure
Secondary	Ischemic changes to the hand	It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.	Within 24 hours after the procedure
Secondary	Post-procedural pain	Assessed by numerical rating scale (NRS) for pain, which is an 11 point subjective scale (0-10) where 0 refers for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-10 for severe pain.	Within 24 hours after the procedure
Secondary	Number of patient with Radial Artery Occlusion on follow up	Radial artery patency was checked by evaluating radial pulse and Doppler Ultrasonography.	After 4 weeks of the procedure.
Secondary	Patient satisfaction of the used compression methode Assessed by Likert scale for satisfaction	Assessed by Likert scale for satisfaction , which is a 5 point subjective scale (1-5) where 1 refers for Not at all satisfied , 2 for slightly satisfied , 3 for moderately satisfied, 4 for Very satisfied and 5 for Extremely satisfied.	Within 24 hrs